1. Field of the Invention
Embodiments of the invention relate to swallowable viable cells delivery devices. More specifically, embodiments of the invention relate to swallowable delivery devices for delivering viable cells to the small intestine and other solid tissues.
While there has been an increasing development of new viable cells in recent years for the treatment of a variety of diseases, many including proteins, antibodies and peptides have limited application because they cannot be given orally. This is due to a number of reasons including: poor oral toleration with complications including gastric irritation and bleeding; breakdown/degradation of the viable cells compounds in the stomach; and poor, slow or erratic absorption of the viable cells. Conventional alternative viable cells delivery methods such as intravenous and intramuscular delivery have a number of drawbacks including pain and risk of infection from a needle stick, requirements for the use of sterile technique and the requirement and associated risks of maintaining an IV line in a patient for an extended period of time. While other viable cells delivery approaches have been employed such as implantable viable cells delivery pumps, these approaches require the semi-permanent implantation of a device and can still have many of the limitations of IV delivery. Thus, there is a need for an improved method for delivery of viable cells and other therapeutic agents.
U.S. Pat. Nos. 8,721,620; 8,759,284; and 8,734,429, all commonly assigned with the present patent application, describe swallowable devices which are optimized for the delivery of proteins and other labile viable cells to a patient's intestines. While very effective for delivering viable cells formulations, these devices are not optimized for delivering living cells to a patient. The delivery of living or viable cells, such as stem cells, cells which secrete therapeutically beneficial agents, and the like, to a patient promises to be of enormous clinical benefit, but is hindered by a shortage of effective delivery apparatus, materials and protocols.
For these reasons, it would be desirable to provide improved and alternative apparatus, materials and protocols for the delivery of viable cells to human and animal patients. At least some of these objectives will be met by the inventions described and claimed herein.
2. Description of the Background Art
U.S. Pat. Nos. 8,721,620; 8,759,284; and 8,734,429 have been described above. See also US2013/0095081 and US 2010/0215715.